Medical Devices

launching medical devices unique device identification (Saudi -DI) system and the Compliance timeframe

launching medical devices unique device identification (Saudi -DI) system and the Compliance timeframe
Publication Date
Applying Date
2020-09-10

Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7)

2022-06-16
Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7)
Requirement
Has the page content helped you?

Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices (MDS-REQ8)

2021-06-21
Requirements for Advertisement Approval and Launching Awareness and Charity Campaigns for Medical devices (MDS-REQ8)
Requirement
Has the page content helped you?

Question

If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?


Answer

In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.


Question

In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure?


Answer

The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.


Question

If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?


Answer

No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.


Question

In the event that a corrective action is issued by the factory, is it necessary for affected customers to be notified immediately even before the corrective plan is provided?


Answer

Yes, and they should be informed again if there are additional corrective or preventive recommendations or actions.


Question

In case of receiving inquiries from SFDA about a medical device Field Safety Corrective Action that they received from more than one source, but for the company is considered as one Field Safety Notice should all of them be closed, or it should be reported that they are the same Field Safety Notice which was previously answered?


Answer

SFDA must be informed of any duplicated Field Safety Notices and any updated information related to affected medical device or the corrective action.


Question

If a new Field Safety Corrective Action is issued and there is no affected device in KSA, but we as a manufacturer know that there is a request for a number of devices that will be available in the Kingdom (e.g. after two months), in this case, does KSA considered affected or not?


Answer

Any affected device should not be imported until the corrective action is implemented and providing SFDA with supporting documents.


Question

Is it required to provide a risk assessment form with each Field Safety Corrective Action?


Answer

Yes


Subscribe to Medical Devices